# K050635: Allfim Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Jul 28, 2005 after 119 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944964 (1995). 52 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041655: Bio Plant System (Implants and Abutments), Cowellmedi Co., Ltd. (2004) Summary page 1.
- K925777: Branemark System Estheticone Abutment Complete, Nobelpharma USA, Inc. (1993) Summary page 1.
- K925779: Branemark System Titanium Healing Abutments, Nobelpharma USA, Inc. (1993) Summary page 1.
- K961728: Miruscone Abutment System, Nobelpharma USA, Inc. (1996) Summary page 1.
- K971706: Tiadapt Abutment System, Nobel Biocare Uas, Inc. (1997) Summary page 1.

## Most influential descendants
- K071148: Atlas Implant System (2008), 4 descendants of its own
- K120043: CSM Internal-R Implant System (2012), 1 descendant of its own
- K090054: Atlas Implant System - Wide Plus (2009), 1 descendant of its own
- K173141: CSM Submerged3-L Implant System (2018), 0 descendants of its own
- K090377: Sinus Quick EB System (2009), 0 descendants of its own

## Indications for use
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction. The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only

Source page: https://510kreport.com/device/K050635
Methodology: https://510kreport.com/methodology